At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 147 enrolled
Drug / intervention
VX-371 + HS +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi
In Brief
A Phase 2 clinical trial evaluating VX-371 + HS, Hypertonic saline, and 3 other interventions for Cystic Fibrosis. Completed, enrolled 147 participants across 40 sites in 4 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of treatment with VX-371 in hypertonic saline compared to hypertonic saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of age, homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation, and being treated with Orkambi
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesFrance, Ireland, United Kingdom, United States
CollaboratorsVertex Pharmaceuticals Incorporated
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedMar 2016
Primary CompletionSep 2017
TodayJul 2026
First PostedMar 15, 2016
Enrollment StartFeb 1, 2016
Primary CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.3 years ago
Interventions
VX-371 + HSdrug
Hypertonic salinedrug
Placebodrug
Orkambidrug
VX-371drug